(33 days)
RayStation 6.0 K170355
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No
The document describes a radiation therapy treatment planning system with various functionalities, but there is no mention of AI, ML, or related terms, nor is there any description of training or test sets typically associated with such technologies.
No
RayStation is a software system for planning and analysis of radiation therapy, not for administering the treatment itself. It generates treatment plans and dose estimates, which are then used by staff to administer treatments. Therefore, it is a treatment planning device rather than a therapeutic device.
No
Explanation: The document describes RayStation as a software system for "treatment planning and analysis of radiation therapy" and "estimates of dose distributions," not for diagnosing diseases or conditions. It aids in crafting treatment strategies, not in identifying medical issues.
Yes
The device description explicitly states that RayStation 6.1 is a "software program for planning and analysis of radiation therapy treatment plans." The functionalities listed are all software-based operations on imaging data. There is no mention of any accompanying hardware components that are part of the device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that RayStation is for "treatment planning and analysis of radiation therapy." This involves planning how to deliver radiation to a patient's body, not analyzing samples taken from the body (which is the core of IVD).
- Device Description: The description reinforces this by detailing features related to dose computation, image fusion, contouring, and optimization – all activities related to planning external radiation delivery.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, urine, etc.), detecting specific analytes, or providing diagnostic information based on in vitro tests.
IVD devices are designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. RayStation's function is entirely focused on planning and analyzing the delivery of radiation to the body.
N/A
Intended Use / Indications for Use
RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user.
The system functionality can be configured based on user needs.
The intended users of RayStation shall be clinically qualified radiation therapy staff trained in using the system.
Product codes (comma separated list FDA assigned to the subject device)
MUJ
Device Description
RayStation 6.1 is a radiation therapy treatment planning system, i.e. a software program for planning and analysis of radiation therapy treatment plans. Functionality includes fusion capabilities (CT, PET and MRI), contouring, collapsed cone convolution dose computation and 4D data compatibility, as well as unique features such as multi-criteria optimization, dose tracking, treatment adaptation and deformable registration, all available on one platform.
The main workflow, creating a treatment plan from imported patient image data, is described below:
Flow of Events:
User: 1. The user launches RayStation 6.1
System:
User: 2. The user imports a patient and case with CT images through DICOM
System: 3. The system imports the data and checks consistency of in-data
User: 4. The user enters the Structure Definition module and creates ROIs using the contouring tools
System: 5. The system adds the ROIs to the patient case
User: 6. The user enters the Plan Setup module and creates a plan and a treatment setup with specified machine, treatment energy and delivery type
User: 7. The user specifies beam configuration including isocenter, dose grid and fluence grid resolution
System: 8. The system adds the plan and treatment setup to the patient case
User: 9. The user enters the Plan Optimization module and optimizes the plan parameters
System: 10. The system generates a deliverable plan
System: 11. The system displays the plan as - 2D and 3D dose and patient displays - DVH curves - Plan data (beams, segments etc.)
User: 12. The user reviews the plan
User: 13. The user enters the Plan Evaluation module and evaluates the plan
User: 14. The user approves and exports the plan together with dose, structure sets and images
System: 15. The system exports the plan and patient data to a DICOM server
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
CT, PET and MRI
Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
clinically qualified radiation therapy staff trained in using the system.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The test specification of RayStation 6.1 is a further developed version of the test specification of RayStation 6.0. This is supported by the requirements specification, for which the same is true. The successful verification and validation of RayStation 6.1 therefore support the substantial equivalence of the above RayStation versions.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
RayStation 6.0 K170355
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 892.5050 Medical charged-particle radiation therapy system.
(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 27, 2017
RaySearch Laboratories AB (publ) % Mr. David Hedfors Ouality and Regulatory Affairs Director Sveavägen 44 Stockholm、111 34 Sweden
Re: K171536
Trade/Device Name: RayStation 6.1 Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: MUJ Dated: May 21, 2017 Received: May 25, 2017
Dear David Hedfors:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device
1
related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Michael D.'Hara For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name RayStation 6.1
Indications for Use (Describe)
RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user.
The system functionality can be configured based on user needs.
The intended users of RayStation shall be clinically qualified radiation therapy staff trained in using the system.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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| Document ID and Title | Version: |
|---|---|
| RSL-D-RS-6.1 Traditional 510(k) Submission RayStation 6.1 | 1.0 |
510(k) Summary 5.
5.1 510(k) owner
RaySearch Laboratories AB (publ) Sveavägen 44 111 34 Stockholm Sweden
Tel: +46 8 510 530 00
5.2 Contact person
David Hedfors Quality and Regulatory Affairs Director RaySearch Laboratories AB (publ) Email: david.hedfors@raysearchlabs.com Tel: +46 722 366 110
5.3 Preparation date
May 18th, 2017
5.4 Trade name
The trade name is RayStation.
The trade name and version number are written together, i.e. "RayStation 6.1" to easily distinguish the submitted device from the predicate device RayStation 6.0.
5.5 Common name
Radiation therapy treatment planning system
5.6 Classification name
Medical charged-particle radiation therapy system (21 CFR 892.5050, Product Code MUJ)
5.7 Predicate device
RayStation 6.0 K170355
5.8 Device description
RayStation 6.1 is a radiation therapy treatment planning system, i.e. a software program for planning and analysis of radiation therapy treatment plans. Functionality includes fusion capabilities (CT, PET and MRI), contouring, collapsed cone convolution dose computation and 4D data compatibility, as well as unique features such as multi-criteria optimization, dose tracking, treatment adaptation and deformable registration, all available on one platform.
The main workflow, creating a treatment plan from imported patient image data, is described below:
| Flow of Events | |
|---|---|
| User | System |
| 1. The user launches RayStation 6.1 | |
| 2. The user imports a patient and case with | |
| CT images through DICOM | 3. The system imports the data and checks |
| consistency of in-data | |
| 4. The user enters the Structure Definition | |
| module and creates ROIs using the | |
| contouring tools | 5. The system adds the ROIs to the patient |
| case | |
| 6. The user enters the Plan Setup module and | |
| creates a plan and a treatment setup with | |
| specified machine, treatment energy and |
4
| Document ID and Title
RSL-D-RS-6.1 Traditional 510(k) Submission RayStation 6.1 | Version:
1.0 |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| delivery type
7. The user specifies beam configuration
including isocenter, dose grid and fluence
grid resolution
-
The user enters the Plan Optimization
module and optimizes the plan parameters -
The user reviews the plan
-
The user enters the Plan Evaluation
module and evaluates the plan -
The user approves and exports the plan
together with dose, structure sets and
images | 8. The system adds the plan and treatment
setup to the patient case -
The system generates a deliverable plan
-
The system displays the plan as
- 2D and 3D dose and patient displays
- DVH curves
- Plan data (beams, segments etc.)
- The system exports the plan and patient
data to a DICOM server |
5.9 Intended use
RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user.
The system functionality can be configured based on user needs.
The intended users of RayStation shall be clinically qualified radiation therapy staff trained in using the system.
The intended use for RayStation 6.1 is the same as for the predicate device RayStation 6.0.
5.10 Technological characteristics summary
The technological characteristics are the same for RayStation 6.1 as for the predicate device RayStation 6.0.
Comparing RayStation 6.1 with RayStation 6.0, the newer version includes usability, computational speed and connectivity improvements. Both versions are built on the same software platform and share design to a high degree. Both versions have been developed under the same quality system meeting the same requirements for safety and effectiveness.
5.11 Assessment of non-clinical performance data
The test specification of RayStation 6.1 is a further developed version of the test specification of RayStation 6.0. This is supported by the requirements specification, for which the same is true. The successful verification and validation of RayStation 6.1 therefore support the substantial equivalence of the above RayStation versions.
5.12 Test conclusion
The summary of the performed non-clinical tests shows that RayStation 6.1 is as safe and effective, and performs as well as the predicate device.